510(k) K881465
- Device
- CRYOBIOLOGICAL FREEZER
- Applicant
- CRYODYNE TECHNOLOGIES, INC.
- 510(k) number
- K881465
- Product code
- KSP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-04-21
- Date received
- 1988-04-06
- Regulation
- 864.9225
- Classification name
- Apparatus, Cell-freezing And Reagents
- Medical specialty
- Hematology
- Review panel
- Pathology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DEAN W SCHILLING
- Address
- 400 Hoover Rd. Soquel CA US 95073 95073
FDA Registration Numbers#
- 3026038437
- 3000184820
- 3002465911
- 3034286704
- 3033918993
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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